Bivona 67PFS50Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10351688518644), received between Oct 4, 2018 and Jun 4, 2024 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (26 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K923878); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 29, 2024Open, Classified

   Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

   Z-2613-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459429 ↗
• MalfunctionMar 26, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE "CANNULA BLOCKING" WAS ONLY POSSIBLE ON ONE SIDE. THERE WAS PATIENT INVOLVEMENT WITHOUT ANY INJURY. THE EVENT AROSE IMMEDIATELY WHEN THE MOTHER CHANGED THE CANNULA. ACCORDING TO THE MOTHER, THE INCORRECT BILATERAL BLOCKAGE RESULTED IN A STRONG COUGH AND POSSIBLY SLIGHT MICRO-ASPIRATION.

  Patient problems: Aspiration/Inhalation; Cough

  MAUDE report 18980764 ↗
• MalfunctionJun 30, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING, THE "TTF" CUFF WAS FAULTY, WHEN BLOCKED BEFORE A CANNULA CHANGE. NO INJURY OR ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241128 ↗
• MalfunctionJun 30, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING, THE "TTF" CUFF WAS FAULTY, WHEN BLOCKED BEFORE A CANNULA CHANGE. NO INJURY OR ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239695 ↗
• MalfunctionMar 7, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT 17 TRACHS WERE NOT INFLATING SYMMETRICALLY WHEN TESTED. ONE OF THE ISSUES WAS FOUND WHILE IN USE. THE REST OF THE ISSUES WERE FOUND DURING PRE-TEST. CUSTOMER DOES NOT REMEMBER WHICH ITEM/LOT NUMBER WAS FOUND WHILE IN USE. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497738 ↗
• MalfunctionMar 7, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT 17 TRACHS WERE NOT INFLATING SYMMETRICALLY WHEN TESTED. ONE OF THE ISSUES WAS FOUND WHILE IN USE. THE REST OF THE ISSUES WERE FOUND DURING PRE-TEST. CUSTOMER DOES NOT REMEMBER WHICH ITEM/LOT NUMBER WAS FOUND WHILE IN USE. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496761 ↗
• MalfunctionJan 20, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TRACHS WERE NOT INFLATING SYMMETRICALLY WHEN TESTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215360 ↗
• MalfunctionDec 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT SEVENTEEN TRACHEOSTOMIES WERE NOT INFLATING SYMMETRICALLY WHEN TESTED. ONE OF THE ISSUES WAS FOUND WHILE IN USE. THE REST OF THE ISSUES WERE FOUND DURING PRE TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060979 ↗
• MalfunctionDec 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT SEVENTEEN TRACHEOSTOMIES WERE NOT INFLATING SYMMETRICALLY WHEN TESTED. ONE OF THE ISSUES WAS FOUND WHILE IN USE. THE REST OF THE ISSUES WERE FOUND DURING PRE TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060873 ↗
• MalfunctionSep 27, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED NO ELBOW CONNECTOR CAME WITH THE PRODUCT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492326 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455505 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455477 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455469 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455462 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455460 ↗
• MalfunctionSep 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS WERE ASYMMETRICAL DURING PRE-TEST. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445143 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DO NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436944 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DO NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436935 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DO NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436913 ↗
• MalfunctionSep 13, 2022Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED THE LED WAS FLICKERING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415075 ↗
• MalfunctionSep 12, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED DURING A SURGERY THE EQUATOR REACHED A TEMPERATURE OF 60C (TEMPERATURE SHOWN ON THE SCREEN DISPLAY). AS A RESULT, THE PATIENT GOT BURNED ON HIS LEFT SHOULDER. THE PATIENT RECEIVED REGIONAL ANESTHESIA. IT WAS THE PATIENT ITSELF WHO SHOUTED THAT HE WAS GETTING BURNED. FROM THIS MOMENT THE DOCTORS TURNED THE MACHINE OFF AND REMOVED IT FROM THE OPERATION ROOM. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406714 ↗
• MalfunctionSep 12, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT AFTER GOING THROUGH AN OPERATION, THE CUSTOMER ATTEMPTED TO CONNECT THE PRODUCT TO A THIRD PARTY'S MEDICAL FLUID INFUSER, BUT THEY WERE UNABLE TO BE LOCKED WITH EACH OTHER FIRMLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403323 ↗
• MalfunctionAug 23, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THREE TUBES WERE ASYMMETRICAL WHEN INFLATED. NEITHER OF THE TUBES WERE USED ON THE PATIENT WHICH HAS DELAYED A ROUTINE TRACH CHANGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280282 ↗
• MalfunctionApr 8, 2021Inflation Problem; Inflation Problem

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636660 ↗
• MalfunctionApr 8, 2021Inflation Problem; Inflation Problem

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636602 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.